CN117202960A

CN117202960A - Packaged catheter assembly

Info

Publication number: CN117202960A
Application number: CN202280031203.XA
Authority: CN
Inventors: V·延科; B·梅恰尔; P·洛科; P·费诺维克
Original assignee: Trio Healthcare Ltd
Current assignee: Trio Healthcare Ltd
Priority date: 2021-04-27
Filing date: 2022-04-26
Publication date: 2023-12-08
Also published as: EP4329851A1; US20220339399A1

Abstract

A packaged catheter assembly comprising a pouch and a catheter, wherein: the catheter is disposed in the bag. The catheter includes at least one steering sleeve configured to provide at least two steering sleeve elements after removal of the catheter from the pouch. The catheter may include a steering sleeve configured to provide at least two steering sleeve elements. The steering sleeve may include a weakened portion including one or more perforations disposed about a circumference of the respective steering sleeve. A method of packaging a catheter, the catheter comprising at least one steering sleeve, the method comprising: providing at least two steering sleeve elements; and disposing the catheter in the pouch using the steering sleeve member. The method may include: separating the at least one steering sleeve into at least two steering sleeve elements; coiling or looping the catheter; and forming a knot in the catheter.

Description

Packaged catheter assembly

Technical Field

The present invention relates to packaged catheter assemblies. In particular, to packaged urinary catheter assemblies, and more particularly, to packaged intermittent male urinary catheter assemblies.

Background

Many people suffer from urinary system diseases, resulting in difficulty in urination. Intermittent catheter assemblies can provide a convenient and portable solution to this problem, as the user can insert the catheter on his own as needed to facilitate/alleviate himself. This reduces the impact of their urinary condition on their lives and allows them to enjoy a relatively normal lifestyle.

Intermittent catheters are typically single-use devices that are carried by the user and then unpacked for use as desired. When using intermittent catheters in public places, it is also advantageous to be able to repack the catheter until it is convenient to discard the catheter. However, this can be difficult, especially for male intermittent catheters that are typically several centimeters longer than female catheters, typically at least 20cm long, with a minimum effective length set at ISO 20696:2018 of 275mm. This makes them difficult to repack in an unobtrusive manner.

It is also important to lubricate the catheter before use in order to reduce the risk of urinary tract damage and to improve the comfort of using the catheter. However, once lubricated and used, the catheter may be slippery and difficult to maneuver. This makes it difficult and unhygienic to repack the catheter after use, as the used catheter may inadvertently come into contact with the user's hands, clothing or personal items.

Existing intermittent catheters, such as Coloplast SpeediCath Flex (RTM) and Hollister VaPro (RTM) catheters, disclose a continuously steerable sleeve that covers the entire length of the catheter. While these provide some assistance to handling, the sleeve must bunch up against one end of the catheter during use, which can be difficult and unhygienic, as dust can fall onto the catheter during bunching of the sleeve prior to use.

It is an aim of embodiments of the present invention to at least partially overcome or alleviate the above-mentioned problems.

Disclosure of Invention

According to a first broad aspect of the present invention there is provided a steering sleeve suitable for use with a catheter, wherein the steering sleeve is configured to provide at least two steering sleeve elements during use of the catheter. The sleeve may be formed of a film material. The present invention may provide a catheter provided with a steering sleeve. The present invention may provide a packaged catheter assembly comprising a pouch and a catheter provided with a sleeve. The catheter may be disposed within the pouch. The steering sleeve may be configured to provide at least two steering sleeve elements after removal of the catheter from the bag.

According to a second aspect of the present invention there is provided a packaged catheter assembly comprising a bag and a catheter, wherein: the catheter is disposed within the bag; and the catheter includes at least one steering sleeve formed of a film material and configured to provide at least two steering sleeve elements after removal of the catheter from the pouch.

Advantageously, the present invention provides a steering sleeve that provides at least two steering sleeve elements that allow for more convenient and easier steering of the catheter before, during, and after use. This may reduce the need to adjust the sleeve prior to use of the catheter, reducing the chance of dirt contacting the catheter and associated infection. Furthermore, the steering sleeve element provides greater flexibility in steering the catheter than a single long sleeve, which makes it easier for the catheter to be repackaged into a pouch after use.

The catheter may include a steering sleeve. In the case of a single actuating sleeve, the actuating sleeve can be configured to provide at least two actuating sleeve elements. Thus, in one example, the catheter includes one steering sleeve configured to provide two steering sleeve elements. Alternatively, the catheter may comprise two or more steering sleeves. Where there are two or more steering sleeves, each steering sleeve may be configured to provide at least one steering sleeve element. Thus, the steering sleeve and steering sleeve elements may be flexibly configured to allow for easier steering of the catheter as they may be optimized for the specific packaging requirements of a given catheter/bag. Thus, they may also be configured to fit users with varying degrees of mobility and flexibility.

The two actuating sleeve elements are preferably separate. The at least one operating sleeve can be configured to be separable into at least two operating sleeve elements. Thus, two or more steering sleeve elements may be kept in a convenient position prior to use, as they form part of the same steering sleeve, which makes the catheter easier to use and the steering sleeve elements easier to access/implement. Providing a detachable steering sleeve may also make the manufacture of the packaging assembly simpler while still providing the benefits of at least two steering sleeve elements.

The at least one handling sleeve may comprise one or more weakened portions to facilitate separation of the sleeve into at least two handling sleeve elements. The or each weakened portion may be one or more perforations. The one or more perforations may be disposed about the circumference of the sleeve. The perforations may extend circumferentially around the circumference of the sleeve. In one example, the catheter may include one steering sleeve, and the steering sleeve may be broken/separated at the puncture to provide two steering sleeve elements. Thus, by tearing the handling sleeve along the perforations, the handling sleeve can be easily separated. This facilitates easy separation without additional tools and the separation process does not create unnecessary loose parts that are difficult and inconvenient to repack back into the bag after use.

The perforations may include a row of holes extending around the circumference of the steering sleeve. The holes may be spaced apart by a distance no greater than the dimension of each hole in a direction parallel to the circumference of the respective steering sleeve. The width and length of each aperture are perpendicular to the width and length of the steering sleeve, respectively (described below). The holes may be elongate. The aspect ratio (length: width) of each aperture may be at least 1.5:1, at least 2:1, at least 3:1, at least 4:1. The holes may be spaced apart by a distance not exceeding 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20% or 10% of the length of each hole. The spacing of adjacent holes may depend on the length of the holes, or the spacing of adjacent holes may be constant regardless of the length of the holes. The holes may be spaced apart by a distance of less than 4mm, less than 2mm, or less than 1 mm. The holes may be spaced apart by a distance of at least 0.4mm, 1mm or 2mm. The length of each aperture may be at least 0.5mm, at least 1mm or at least 2mm. The length of each hole may be less than 6mm, less than 2mm, less than 1mm, or less than 0.5mm. Preferably, the length is 2mm and the holes are spaced apart by a distance of 1 mm. In this way, the perforation provides a weak spot in the handling sleeve sufficient to allow easy separation of the handling sleeve into a plurality of handling sleeve elements.

Each hole forming the perforation may be a slit. Where each aperture is a slit, it may be formed by a one-dimensional cut in the steering sleeve. In the case where each aperture is a slit, its aspect ratio (length: width) may be 1:0 in practice. Each cut may be made at a distance corresponding to the desired length of each hole. Alternatively, the slotted perforations may be formed in any other suitable manner. In some embodiments, each slit may be formed by joining two or more steering sleeve elements end-to-end and sealing adjacent steering sleeve elements at locations that do not correspond to the slit locations. Advantageously, in the case of the aperture being a slit, the catheter is less likely to be exposed by manipulation of the sleeve than in the case of the aperture not being a slit. This helps to prevent accidental contamination of the catheter during handling.

The weakened portions may be provided by a tear strip. The weakened portions may be provided by a release adhesive. The weakened portions may be provided by sealed hook-and-hook or hook-and-loop elements. Thus, the weakened portions may be configured in a variety of different ways.

The at least one steering sleeve may form a sheath around at least a portion of the catheter. The at least one handling sleeve may be tubular, e.g. cylindrical. The at least one steering sleeve may be configured to be separable at a point along its axis. The at least one steering sleeve element may form a sheath around only a portion of the catheter. The at least two steering sleeve elements may each form a sheath around only a portion of the catheter. The at least one handling sleeve element may be tubular, e.g. cylindrical. The at least two steering sleeve elements may each be tubular, for example cylindrical. Thus, the steering sleeve provides a sheath around the catheter and may be split into a plurality of steering sleeve elements that also provide a sheath around a portion of the catheter, thereby facilitating easy steering of the catheter without the user having to directly contact the catheter.

The at least one steering sleeve may be formed from one or more strips of material joined together along their edges. The engagement may be provided by any suitable means, such as welding; mechanical sealing; heat sealing; sealing under pressure; an adhesive; solvent bonding; ultraviolet light combination; ultrasonic welding; laser welding; pulse welding; or friction welding. The strip of material may be elongate. Where the strips of material are elongate they may be joined along their elongate edges. The strip of material may be trapezoidal. Thus, by welding together the elongated sides of each strip of material, the handling sleeve can be easily manufactured on a production line. This may eliminate the need for the catheter to pass through the sleeve during manufacture, which is a complex process.

The weakened portions in the actuating sleeve may be formed after the actuating sleeve is formed. In such embodiments, it may be convenient when the or each steering sleeve element is formed from a single/same type of material. In embodiments where the frangible site is a perforation, the perforation may be cut into/into the steering sleeve. Alternatively, the weakened portions may be formed during formation of the handling sleeve. In some embodiments, the steering sleeve may be formed from two or more steering sleeve elements joined end-to-end. This may be convenient in case the or each steering sleeve element is formed from a different strip of material. In one example, the weakened portions may form end-to-end joints between adjacent operating sleeve elements. For example, the ends of the individual steering sleeve elements may be intermittently welded together to form perforations at the joint/junction. In other examples, any suitable engagement means may be used, such as a mechanical seal; heat sealing; sealing under pressure; an adhesive; solvent bonding; ultraviolet light combination; ultrasonic welding; laser welding; pulse welding; or friction welding. Thus, the weakened portions may conveniently be formed in the or each handling sleeve.

Each steering sleeve may have a length measured parallel to the catheter axis and a width measured perpendicular to the catheter axis. The width of each steering sleeve may be constant along at least a portion of its length. The width of the steering sleeve may vary along at least a portion of its length. The length of the steering sleeve may be less than: 275mm;250mm;200mm;150mm;125mm; or 100mm. The length of the steering sleeve may be at least: 50mm;100mm;125mm;150mm;200mm; or 250mm. Preferably, the length of the steering sleeve may be in the range 120-100mm, more preferably 110mm. The width of the steering sleeve may be less than: 60mm;40mm;30mm;25mm;20mm; or 15mm. The width of the steering sleeve may be at least: 10mm;15mm;20mm;25mm;30mm; or 40mm. Preferably, the width of the handling sleeve is in the range of 15-25 mm. Thus, each steering sleeve and each corresponding steering sleeve element can be manufactured to ensure that it has the correct width to ensure that it is both easy to use and fits tightly into the catheter.

In the case where the width of the steering sleeve is constant along at least a portion of its length, it may be formed from two rectangular strips of material. In one example, a rectangular strip of material is 110mm long and 19mm wide. At least a portion of the steering sleeve may be tapered/conical. The width of the tapered portion may increase or decrease along the length of the tapered portion of the steering sleeve. The conical portion of the steering sleeve may be formed from an isosceles trapezoid of strips of material. When the strips of material are isosceles trapezoids, they may be joined together along their side/hypotenuse edges. In one example, the strip may have a length of 110mm (i.e., the height of an isosceles trapezoid) and a width that varies from 23mm at one end to 17mm at the other end. Thus, the steering sleeve and steering sleeve member may be conveniently manufactured from a variety of different sized strips of material to ensure a good fit with the catheter and ease of use. In the case where a portion of the steering sleeve is tapered/conical, this has the additional benefit that the steering sleeve, and any corresponding steering sleeve elements, are less likely to be inadvertently removed from the catheter due to the narrower width of one end. Furthermore, the wider ends of the tapered portions may be more easily fitted over the ends of the catheter to allow for easy handling of them/the ends without the user having to directly touch them/the ends and without the handling sleeve falling off the catheter.

Each steering sleeve element may be formed as part of a respective steering sleeve. Each steering sleeve element may be at least 20%, at least 30%, at least 40%, at least 50%, at least 60% or at least 70% of its respective steering sleeve length. The length of the handling sleeve element may be at least 35mm, at least 45mm, at least 55mm, at least 65mm or at least 75mm, and preferably 55mm. Where the steering sleeve comprises two or more steering sleeve elements, each steering sleeve element is preferably of the same length. Alternatively, where the steering sleeve includes two or more steering sleeve elements, one or more steering sleeve elements may have different lengths. In the case of a steering sleeve comprising two steering sleeve elements, the length ratio of the elements may be in the range 50:50 to 70:30, or more preferably in the range 50:50 to 60:40. Thus, the steering sleeve elements are sized to ensure that the user has sufficient room to hold each steering sleeve element before, during and after use of the catheter.

The catheter may be a urinary catheter. The catheter may be a male urinary catheter. The catheter may be an intermittent catheter. In one embodiment, the catheter is an intermittent male urinary catheter. Thus, the features of the present invention allow intermittent male urinary catheters to be provided in a compact package that also facilitates convenient and easy removal, use and repackaging of the catheter.

The catheter may include a distal end and a proximal end for insertion into the body. The catheter may include a funnel at its distal end. The funnel may facilitate easier manipulation of the catheter. Where the catheter is a urinary catheter, the funnel may allow the user to better direct urine as it exits the catheter during use. The at least one handling sleeve and/or the handling sleeve element may be configured to cover the funnel. At least one steering sleeve and/or steering sleeve element may be arranged at the distal end, for example around or near the funnel prior to removal of the catheter from the bag. The distal end and/or funnel may be removed from the bag prior to removal of the proximal end from the bag. Thus, the steering sleeve/steering sleeve elements may be arranged such that they can be used to remove the catheter from the bag, which helps to ensure that the catheter remains clean and sterile prior to use and reduces the risk of infection. Furthermore, since the steering sleeve elements may overlie the funnel, they may reduce the likelihood of contacting the funnel end during repacking of the catheter after use. This makes the use of a repackaged catheter more hygienic to the user.

The steering sleeve and/or one or more steering sleeve elements are movable along the length of the catheter. Each steering sleeve member is independently movable along the length of the catheter. One or more steering sleeves and/or steering sleeve elements may not be connected to the catheter. Preferably, the or each steering sleeve and each steering sleeve element may not be connected to a catheter. Thus, by moving the steering sleeve member along the catheter, the catheter can be more conveniently steered to suit the environment and requirements of the user. Alternatively, one steering sleeve element may be movable along the length of the catheter, and one steering sleeve element may be connected to the catheter. In particular, one of the steering sleeve elements closest to the distal end of the catheter may be coupled to the catheter, and one of the steering sleeve elements closest to the proximal end of the catheter may be movable along the length of the catheter.

The one or more steering sleeve elements may be configured to enable placement of the catheter in the bag after use. The steering sleeve element may comprise a proximal steering sleeve element and/or a distal steering sleeve element. A proximal steering sleeve element may be disposed at the proximal end of the catheter after use. A distal steering sleeve element may be disposed at the distal end of the catheter. The steering sleeve element may comprise one or more steering sleeve elements, which may be disposed at the midpoint of the catheter, or at a location closer to the midpoint than the ends of the catheter. The proximal and/or distal steering sleeve elements may be disposed at a midpoint of the catheter or at a location closer to the midpoint than the ends of the catheter. In a preferred embodiment, the steering sleeve member comprises a distal steering sleeve member and a proximal steering sleeve member. Thus, the steering sleeve member may be configured to be disposable at a convenient location along the catheter.

At least one of the two or more steering sleeve elements may be configured to simultaneously receive and/or retain at least two sections of the catheter. The two or more steering sleeve elements may be configured to hold the catheter in an annular or coiled configuration. Where the steering sleeve element receives at least first and second sections of the catheter, the catheter may be looped between the first and second sections. The one or more steering sleeve elements may be configured to receive and/or retain an end of a catheter. Preferably, the one or more steering sleeve elements may be configured to receive and/or retain the proximal end of the catheter. The distal steering sleeve member may be configured to receive and retain the proximal end of the catheter. Thus, the size/shape of the catheter may be limited by the steering sleeve and ensure that the catheter can be easily repackaged back into the bag. The use of two or more steering sleeve elements also allows the shape of the catheter to be more constrained than when using a single steering sleeve element.

At least a portion of the catheter may be configured to be wetted during removal of the catheter from the pouch. At least a portion of any one or more of the at least one steering sleeve may be configured to not become wetted during removal of the catheter from the bag. At least a portion of each steering sleeve member may be configured to not become wetted during removal of the catheter from the bag. Less than 50%, less than 40%, less than 30%, less than 20%, or less than 10% of the steering sleeve length may be configured to be wetted during catheter removal from the pouch. The at least one steering sleeve member may be configured to not be wetted during removal of the catheter from the bag. Thus, the catheter may be sufficiently lubricated for use without significantly affecting the steering sleeve or steering sleeve element.

The steering sleeve and/or steering sleeve member may be formed from any suitable film material. The steering sleeve and/or steering sleeve element may be fluid impermeable. The actuating sleeve and/or the actuating sleeve element can be made of a plastics material. The steering sleeve and/or steering sleeve element may be made, for example, from any one or more of the following: polypropylene (PP), low Density Polyethylene (LDPE), high Density Polyethylene (HDPE) or biaxially oriented polypropylene (BOPP). The catheter and/or the bag may be made of the same or different material as the steering sleeve and/or the steering sleeve element. In a preferred embodiment, the catheter is a hydrophilic thermoplastic elastomer (TPE) and the steering sleeve and/or steering sleeve element is LDPE. Where the conduit includes a funnel, the funnel may be Polyvinylchloride (PVC). Thus, the steering sleeve and/or steering sleeve element, and the catheter and funnel may be made of suitable materials.

The pouch may comprise two walls and a peripheral seal between the two walls. The catheter may be disposed in the pouch in a curved configuration. A junction may be provided between the two walls of the bag. The junction and the inner base of the peripheral seal may define a channel to be filled with fluid prior to removal of the catheter from the pouch. The pouch and catheter may be arranged such that during removal of the catheter from the pouch, the distal end of the catheter is removed from the pouch before the proximal end and the proximal end of the catheter pass through the channel. The one or more steering sleeves may be arranged not to pass through the channel during removal of the catheter from the bag. Thus, the catheter may be removed and simultaneously lubricated without the one or more steering sleeves passing through the channel and being lubricated. Furthermore, since the steering sleeve does not pass through the channel, any risk of the steering sleeve being damaged or inadvertently separated into one or more steering sleeve elements during removal of the catheter is reduced.

The one or more steering sleeves may be disposed about a section of the catheter that is not intended for insertion into the body. The one or more steering sleeves may not be disposed about a section of the catheter intended for insertion into the body. During removal of the catheter from the bag, a section of the catheter not intended for insertion into the body may not be arranged through the channel. The section of the catheter intended for insertion into the body may be arranged to pass through the channel during removal of the catheter from the bag. Thus, the one or more steering sleeves do not inhibit lubrication of the catheter as it passes through the channel during removal of the bag.

The packaged catheter assembly may include a fluid reservoir. The fluid reservoir may be configured to release fluid into the bag to form a pool of fluid in the channel. The volume of the fluid reservoir is preferably sufficient to completely fill the channel, i.e. with the bag keeping its base at a minimum, the fluid may extend to at least the height of the bottom of the junction, such that the filling level of the channel is 100% or higher, such as at least 150%, at least 200% or even at least 300%. Alternatively, the filling level of the channel may be: at least 70%, at least 80%, at least 90% of the channel volume; or at least 95%. The at least one handling sleeve element may be arranged above the filling level of the channel before the catheter is removed from the bag. Accordingly, the present invention provides an assembly having a reservoir capable of delivering a fluid into a channel. The dimensions of the reservoir are chosen to ensure that sufficient fluid is delivered and that the catheter is sufficiently lubricated upon removal, and furthermore, the at least one handling sleeve element remains above the filling level and in a dry state, so that handling of the catheter is facilitated.

The bag may be sealed. The fluid reservoir may be arranged in a (sealed) bag. The fluid reservoir may be provided as a separate device or incorporated into the bag material. The fluid reservoir may comprise a deformable, frangible or rupturable bladder. Thus, the fluid reservoir is conveniently located within the bag where it can release fluid directly into the channel formed by the junction and the base of the peripheral seal. The deformable, frangible or rupturable reservoir enhances the convenience of the user because the fluid can be easily released without the need for additional tools and before the pouch is unsealed, thus reducing the chance of accidental wetting by the user. In particular, the bladder can be easily handled/processed on an assembly line and can be introduced more simply than if the handling/processing of the fluid were attempted, in order to introduce it into the package during manufacture.

The conduit may be disposed between the junction and the inner base of the peripheral seal. The engagement portion may be separate/spaced apart from the base portion of the peripheral seal portion. The channel may be an open ended channel. Thus, the catheter is held within the pouch in the open ended channel formed by the junction and the inner base of the peripheral seal. Thus, when withdrawn, the catheter is withdrawn through the passage and is sufficiently lubricated.

The junction and the peripheral seal may be separate. The engagement may be provided at one point. The joint is preferably provided by a weld, for example a spot weld. Such a weld may be provided after the conduit (and optionally the balloon) has been arranged between the walls, and may be achieved from outside the bag. Alternatively, the engagement portion may be provided by any one of: mechanical sealing; heat sealing; sealing under pressure; an adhesive; solvent bonding; ultraviolet light combination; ultrasonic welding; laser welding; pulse welding; or friction welding. Similarly, the peripheral seal is provided by any one or more of the following: welding; mechanical sealing; heat sealing; sealing under pressure; an adhesive; solvent bonding; ultraviolet light combination; ultrasonic welding; laser welding; pulse welding; or friction welding. At least a portion of the peripheral seal may be formed by a fold. In such embodiments, a single sheet may be folded, for example, at the bottom edge or at one of the two side edges, to form two opposing walls of the bag. The joint may be provided at a single location, allowing the peripheral seal and the joint to be formed separately. Alternatively, the weld forming the joint may be provided simultaneously with the peripheral seal. In some embodiments, the junction and the peripheral seal are a single continuous seal. The manufacturing process of the joint is thus very convenient and avoids significant modifications to the production line of typical packaged catheter assemblies.

The conduit may include a surface activated by fluid in the channel. For example, the catheter may include a hydrophilic surface, such as formed by a hydrophilic coating. Where a hydrophilic surface is provided, the fluid may be polar or water-based. The conduit may include a hydrophobic surface activated by the fluid in the channel. For example, the catheter may include a hydrophobic coating. In the case of a hydrophobic coating, the fluid may be non-polar. Thus, the catheter is easily lubricated by the fluid in the channel and is easy and comfortable to use.

The steering sleeve may include a surface that is not activated by the fluid. The surface of the steering sleeve may be hydrophobic. The inner surface of the steering sleeve may be hydrophobic. The steering sleeve may be embossed with a pattern. The inner surface of the steering sleeve may be embossed with a pattern. The pattern may be a linen pattern. Preferably, in use, the inner surface of the steering sleeve adjacent the catheter is hydrophobic and is embossed with a pattern. Advantageously, this reduces friction between the steering sleeve and the catheter in use. In some embodiments, the surface characteristics of the partial steering sleeve or the individual steering sleeve elements may vary depending on their function. For example, in the event that a portion of the steering sleeve or the steering sleeve element is not intended to move along the length of the catheter, its surface characteristics may be selected to increase friction between the steering sleeve and the catheter. Thus, the surface characteristics of the steering sleeve may be selected to ensure that the steering sleeve and catheter are easy to use.

The pouch may include an interaction region defining a first contact point for a user of the catheter assembly for packaging. The interaction region may facilitate access to the contents of the pouch by a user. Actuation of the interaction region may create an opening in or near the upper edge of the peripheral seal. The catheter may be withdrawn through the opening. Thus, access to the bag is provided at or near the upper edge of the bag, such that when the catheter is removed, fluid in the channel (at the bottom of the bag) is retained in the bag, thereby reducing the risk of fluid spilling out of the bag.

The interaction region may comprise a frangible region of the peripheral seal. The method may include forming a frangible region in the peripheral seal. The frangible region may comprise a tear region, which may comprise a tear line defining a line along which the bag may be torn to at least partially separate the tear region from the remainder of the bag, thereby forming an opening in the peripheral seal. The tear region may include a tear initiation. The tear initiation may be disposed at a first end of the tear region. The tear initiation may comprise a notch or weakened area in one or both walls of the bag. The tear initiation may define a first portion of the pouch to be torn. The tear region may include a tear stop. The tear stop may be disposed at a second end of the tear region. The tear stop may be used to prevent or reduce the likelihood of the tear region being completely separated from the remainder of the package. The tear region may be substantially triangular with an inclined upper edge. Thus, the frangible region provides a convenient and easy way to open the pouch with minimal effort and without the need for additional equipment/tools.

The interaction region may comprise a sealing means. The sealing means may comprise one or more sealing members operable to provide a user-sealable seal between the two walls of the bag, thereby closing the bag. In one embodiment, the first and second sealing members are provided on the inner surfaces of both walls of the bag. When closed, the sealing means may provide a watertight and/or fluid impermeable seal. Thus, the bag may be resealed to ensure that the fluid in the passageway is not subsequently released from the bag after use. This also allows the catheter to be repackaged back into the bag after use and remain therein.

The sealing means may be pre-sealed. In such embodiments, the user may access the contents of the pouch by opening the sealing device. The sealing means may be resealable. The sealing means may be any of the following: sealing the zipper lock; hook and loop seals; hooks and hook seals; or an adhesive layer. Thus, the sealing means may be used to ensure that the contents of the bag remain inside until the sealing means is opened and the bag may still be resealed after use. This may be helpful in situations where the frangible region requires a force to be applied to the bag to open, as the bag may move or slosh in place when the bag is opened, resulting in fluid or tubing flowing out of the bag.

The interaction region may comprise a frangible region and a sealing means. In certain embodiments, the interaction region includes a tear region corresponding to an upper edge of the peripheral seal, and a resealable sealing device below the tear region.

The peripheral seal may have an upper edge. The peripheral seal may be substantially rectangular in shape with two side edges between the base and the upper edge. The peripheral seal may have a height from the base to the upper edge of at least 10cm, at least 15cm, or at least 20cm; and/or a height of no more than 10cm, no more than 15cm, no more than 20cm or no more than 25cm, for example a height in the range of 15cm to 20 cm. The width of the peripheral seal between the side edges may be at least 5cm, at least 10cm; or at least 15cm; and/or a width of not more than 10cm or not more than 15cm, or not more than 20cm, for example in the range of 5cm to 15 cm. The length of the conduit may be at least: 20cm;25cm;30cm;35cm;40cm;45cm; or 50cm, for example in the range of 35cm to 45 cm. In one embodiment, the peripheral seal has a height of 10-25cm and a width of 6-11cm, and the conduit has a length of at least 30 cm. Thus, the peripheral seal defines a "pocket-sized" pouch that is capable of storing a catheter therein in a curved configuration to reduce the apparent size of the catheter and to facilitate and unobtrusive storage.

The at least one of the one or more steering sleeves may be disposed at or near a distal end of the catheter. The distal end of the catheter may be disposed closer to the upper edge of the peripheral seal than to the base of the peripheral seal. The distal end of the catheter may be disposed in the upper half of the pouch, or in the upper quarter of the pouch. The distal end of the catheter may be disposed over the junction. The distal end of the catheter may be arranged above the filling level of the fluid. Thus, the distal end of the catheter is easily accessible and provides a user with a steering sleeve so that the catheter can be conveniently removed using the steering sleeve. The steering sleeve is also positioned so as not to be pulled through the fluid and so not to be wetted and will remain easy to handle.

The distal end of the catheter may be provided with at least one steering sleeve which may be arranged closer to the upper edge of the peripheral seal than to the base of the peripheral seal. At least a portion of the handling sleeve may be arranged in the upper half of the bag or in the upper quarter of the bag. At least a portion of the steering sleeve may be disposed above the engagement portion. At least a portion of the steering sleeve may be arranged above the filling level of the fluid. The steering sleeve is thus easily accessible so that it can be withdrawn prior to proximal withdrawal of the catheter as required by the present invention. The steering sleeve is also positioned so as not to be pulled through the fluid so that at least a portion thereof is not wetted and will remain easily handled, thereby providing a dry surface that can be grasped and used to steer the catheter.

The engagement portions may be disposed at points equidistant from each side edge. Alternatively, it may be offset. The method may include providing the engagement portion at a point equidistant from each side edge. Alternatively, it may comprise providing the engagement portion at an offset lateral position. For example, it may be arranged anywhere in the range of 25% to 75% of the width of the bag. The distance between the left and right side edges of the peripheral seal may be the width of the bag. The distal end of the catheter may be disposed no more than 20%, 10%, 5% or 1% of the width of the pouch from one left edge. Thus, the junction and distal end are positioned so that the catheter is easy to remove and lubricate without spilling lubricant. Providing junctions equally spaced between the edges ensures that the channel volume is limited and that the fluid level therein is optimized for lubricating the conduit.

The distal end of the catheter may be disposed closer to one (e.g., left) side edge of the peripheral seal than to the other (e.g., right) side edge of the peripheral seal. In embodiments including an interaction region, actuation of the interaction region may preferably first create an opening in a first (e.g., left) side edge of the peripheral seal. In such embodiments, the distal end of the catheter may be disposed closer to the first (e.g., left) side edge. In embodiments including a tear region and a tear initiation, the location of the tear initiation may correspond to a side edge of the peripheral seal. In such embodiments, the distal end of the catheter may be disposed closer to the side edge of the peripheral seal portion corresponding to the location of the tear initiation portion. One or more steering sleeves and/or steering sleeve elements may be disposed at the distal end of the catheter. Thus, the distal end and the corresponding handling sleeve/handling sleeve element are located near the first portion of the bag to be opened and are easier to remove.

The engagement portion may be disposed closer to the base of the peripheral seal than to the upper edge of the peripheral seal. The distance between the base and the upper edge of the peripheral seal may define the height of the bag. The distance between the engagement portion and the base portion may be at least: 10% of the bag height; 15%;20% of a base; 25%;30%;35%;40% or 45%. The distance between the engagement portion and the base portion may be less than: 50% of the bag height; 45%;40%;35%;30%;25%;20% of a base; or 15%. In particular, the joint may be arranged at between 20% and 30% of the height of the bag. The engagement portion may be circular. The radius equivalent of the joint may be less than 15% of the height of the bag; 10%;5%; or 1%. In a preferred embodiment, the radius of the joint is 5% of the height of the bag. Thus, the joint may be arranged to ensure that the catheter is sufficiently lubricated, and it defines a channel of suitable dimensions to allow the catheter to be easily removed without excessive bending of the catheter or application of excessive force.

In one embodiment, the joint is provided at a point equidistant from each side edge of the bag and a distance from the base of 20-30% of the height of the bag.

The distal end of the catheter may be provided with a funnel arranged not to pass through the channel during removal of the catheter from the bag. The one or more steering sleeves may also be arranged not to pass through the channel during catheter removal. The one or more steering sleeves may not exceed: 25% of the length of the catheter; 20% of a base; 15%;10%; or 5%, but may be longer. Embodiments of the present invention provide a funnel and at least one steering sleeve to allow easy steering of the catheter. These elements, or at least a part of them, do not pass through the channel and are therefore not coated with fluid during removal. This makes the catheter easier to use, as the fluid is applied to only the necessary parts of the catheter. This also facilitates the use of less fluid as it is applied to the catheter in a targeted manner.

When bent in a bag, the end of the catheter may be at least at an angle to: 180 °;210 °;240 °;270 °;300 °;330 °; or 360 °; it may even be at least 420 °;480 ° or 540 °. It may be less than 720 °; less than 630 ° or less than 540 °. The catheter may be disposed in the pouch in a curved or coiled configuration prior to use, after use, or both. Prior to use, the catheter may be arranged such that the junction is located within an area defined by the curved or coiled portion of the catheter. After use, the catheter may be arranged such that the junction is not disposed within the area defined by the curved or coiled portion of the catheter. The peripheral seal may constrain the catheter in its curved configuration. In this way, the catheter is curved, bent or coiled to reduce the size of the bag and to ensure that the long catheter can be conveniently and unobtrusively stored for use.

The catheter may be arranged such that during withdrawal at least: 30% of the length of the catheter; 40%;50%;60 percent; 70% of the total weight of the steel sheet; or 80% pass through the channel. In one embodiment, 70-80% of the length of the catheter passes through the channel during withdrawal. Advantageously, only the portion of the catheter intended to enter the body is lubricated, so fluid is not wasted and the catheter is easier to use.

The walls may be formed of any suitable material, such as a film material. The walls may be fluid impermeable. The walls may be made of a plastic material. The wall may be made of, for example, one or more of the following: polypropylene (PP), polyethylene terephthalate (PET), low Density Polyethylene (LDPE), metallized polyester (MET PET), or oriented polypropylene (OPP). The wall may comprise a laminate of two or more layers. Each wall may include an inner layer and an outer layer. Each wall may comprise an inner layer and an outer layer of polypropylene. Each wall may include an inner oriented polypropylene layer and an outer polypropylene layer. For example, each wall may comprise an inner polypropylene layer and an outer polyethylene layer. The inner layer and the outer layer may have the same thickness. In other embodiments, the inner and outer layers may have different thicknesses. The inner layer may have a smaller thickness than the outer layer. In embodiments, the inner layer may have a thickness of 5-20 microns, or 10-10 microns, or 10-15 microns, and the outer layer may have a thickness of 10-50 microns, or 20-40 microns, or 35-45 microns. In one example, the inner layer may have a thickness of about 12 microns and the outer layer may have a thickness of about 40 microns.

The bag may be an opaque bag. The bag may comprise a transparent or translucent window (preferably corresponding to the position of the fluid reservoir in the bag and/or the wetted area into which fluid is intended to flow from the fluid reservoir). The catheter and/or one or more steering sleeves may be disposed in the bag so as to be shielded from view. A fluid reservoir may be provided within the pouch, and the pouch may be configured to allow a user to view the fluid reservoir and/or view the fluid released from the fluid reservoir.

The present invention thus provides a packaged catheter assembly that is unobtrusive as the contents of the assembly are obscured. The window provides a visual guide so that during use of the catheter, a user can easily identify the fluid reservoir and/or easily identify that fluid has been successfully released from the reservoir into the wetted area of the pouch to lubricate the catheter prior to use. While providing a transparent/translucent window is a preferred method of allowing a user to see if the fluid has been successfully released from the reservoir, alternative methods are also considered to be viable. For example, rather than providing a transparent/translucent window in the opaque wall of the bag, it is contemplated that this function could be accomplished by: a transparent/translucent bag wall is provided but includes an intermediate opaque wall disposed in the bag between the transparent/translucent bag wall and the catheter (and optional reservoir). The intermediate wall may include a window, or fluid released from the reservoir may flow between the outer transparent/translucent wall and the intermediate wall, thereby providing an indication of successful release.

The pouch may comprise two opaque walls. A window may be provided in one of the opaque walls. The window may be spaced apart from at least one edge of the bag or the wall in which the window is disposed. The window may be spaced from all edges of the bag. The window may be smaller than: 25% of the total area of the walls of the bag and/or the window provided therein; 20% of a base; 15%;10% or 5%. The window may correspond to the size and/or shape of the fluid reservoir. The window may be smaller in size than the fluid reservoir. In one embodiment, the window is the same shape as the fluid reservoir, but is smaller in size than the fluid reservoir. Thus, in an embodiment of the invention, the window advantageously corresponds to the size, shape and position of the fluid reservoir and is provided in a discrete manner separate from the edge of the bag and provided in only one section of the bag wall.

The window may correspond to the location of the indicator region of the pouch. The indicator region may correspond to a wetting region that may extend from the base of the pouch to a height sufficient for fluid to spill from the pouch to wet the catheter. The indicator region may be configured to indicate successful release of fluid from the reservoir. The indicator region may include a fill level indicator that indicates that there is sufficient fluid in the wetting region. Thus, the window also provides a visual guide to ensure that the fluid released from the reservoir has been delivered to a specific area (e.g., channel) of the bag or has successfully lubricated the catheter.

The pouch may be substantially rectangular with two side edges, a base and an upper edge. The height of the pouch may be defined as the distance between the base and the upper edge. The width of the pouch may be defined as the distance between the side edges of the pouch. The window may span at least: 20% of the bag height; 30%;40%;50%;60 percent; 70% of the total weight of the steel sheet; 80% or 90%. In one embodiment, the window spans at least 30-40% of the bag height and the window is between 15-20% of the bag width. Thus, when the window is aligned with the fluid reservoir, the fluid reservoir is easily visible, but at the same time, the area of the window is minimized to ensure that the contents of the pouch remain substantially invisible, as the pouch is opaque except for the window.

The conduits in the bag are preferably shielded. The catheter may be shielded by an opaque wall of the pouch. The conduit may be shielded by the fluid reservoir. The one or more handling sleeves in the bag are preferably shielded. The one or more handling sleeves may be obscured by the opaque wall of the bag. The one or more steering sleeves may be shielded by a fluid reservoir. This is particularly advantageous from a judgment point of view-the catheter and the steering sleeve may look like a certain medical instrument to the observer even if they do not know their exact nature; blocking it can obscure it, either by ensuring that it is not aligned with the window, or by blocking it behind another object, such as a fluid reservoir (but alternatively, for example, a dedicated sheet).

Notably, the fluid reservoir (or other obscuring object) may be opaque and may have a color that corresponds to or contrasts with the color of the bag wall. For example, the reservoirs (or other obscuring objects) may be the same color but have a different shade than the color of the bag, or in the case of opaque bags having multiple colors, may be the shade of one of these colors. Grey or silver is considered particularly preferred for the reservoir (or other obscuring object) from a non-attractive perspective.

The one or more steering sleeves and/or one or more steering sleeve elements may be opaque and have a color that corresponds to or contrasts with the color of the catheter and/or bag wall. Thus, the steering sleeve may be configured to resemble the color of the bag and/or catheter, thereby providing a less noticeable catheter.

The window may be patterned; that is, at least a portion of the window may have a pattern disposed thereon, such as a pattern formed by opaque regions, such as spots, stripes, and the like. The pattern may provide a gradual appearance to the window. The pattern may provide a gradual appearance to one or more edges of the window. The pattern may blend the window into the surrounding packaging of the pouch. Thus, the window is less noticeable to an untrained eye, and thus the packaged catheter assembly (both before and after use) is less noticeable to the user.

A retaining seal may be provided between the two walls to limit movement of the fluid reservoir (which may of course be a bladder as defined above) in the bag. The retention seal may be disposed outside of the conduit bend. The retention seal may be closer to the upper edge of the peripheral seal of the pouch than to the base of the pouch. The retention seal may extend from an upper edge of the peripheral seal of the bag.

According to a third aspect of the present invention there is provided a method of packaging a catheter, wherein the catheter comprises at least one steering sleeve, the method comprising: providing at least two steering sleeve elements; and disposing the catheter in the pouch using the steering sleeve member.

The method may include first opening the packaged catheter assembly to provide a catheter and a pouch. The packaged catheter assembly may be a packaged catheter assembly as generally defined, or a packaged catheter assembly according to the second aspect described above, alternatively including any of the optional features described above. Indeed, it may comprise any optional feature, not necessarily all features set out in the second aspect above.

The method may include separating the at least one steering sleeve into at least two steering sleeve elements. Thus, the at least one steering sleeve may be separated to provide a plurality of steering sleeve elements which enable easier and more convenient packaging of the catheter.

The method may include moving one or more steering sleeve elements along the length of the catheter. Thus, the steering sleeve element can be easily arranged to assist in steering different parts of the catheter.

The catheter may include a proximal end for insertion into the body, and a distal end. The method may include disposing a steering sleeve element at or near the distal end of the catheter, i.e., a distal steering sleeve element. The method may include disposing a steering sleeve element at or near the proximal end of the catheter, i.e., a proximal steering sleeve element. Thus, the end of the catheter can be conveniently packaged without touching the used catheter surface itself.

The method may comprise coiling or encircling/looping the catheter. The method may comprise accommodating at least the first and second sections of the catheter within at least one steering sleeve element, preferably at one steering sleeve element. The method may include encircling the conduit between the first and second sections of conduit. The first section may be one end of the catheter, preferably the proximal end. The second section may not be the end of the conduit. The method may include disposing a first steering sleeve element along the catheter at a point corresponding to the second section. The method may include inserting an end of a catheter into a first steering sleeve member. The second steering sleeve member may be used to insert an end of a catheter into the first steering sleeve member. Preferably, the first steering sleeve element is a distal steering sleeve element. Thus, two or more steering sleeve elements may be used to tightly loop the catheter to limit its size/shape.

The method may include forming a knot in the catheter. The method may include forming a loop in the catheter using two or more steering sleeve elements. The method may include threading one end of the catheter through the loop to form a knot. Preferably, the distal end may pass through the ring. Thus, the size/shape of the catheter may be further limited by knotting the annular catheter. Furthermore, both ends of the catheter are held in place to ensure that the catheter is easily repacked in the bag.

The method may include disposing the distal end alongside or in contact with the proximal end. The method may include securing the distal end to the proximal end. The method may comprise arranging the conduits in a circular or ring shape. The catheter may comprise a funnel disposed at its distal end. The method may include inserting the proximal end into the distal end and vice versa. The method may include inserting the proximal end into the funnel. The method may include compressing the funnel to retain the proximal end therein. Thus, the ends of the catheter are joined together to form a circular shape, which makes the catheter easier to handle/handle and package.

The method may include restricting the shape of the catheter using two or more steering sleeve elements. The method may include grasping two or more of the two or more steering sleeve elements with one hand. The method may include inserting the catheter into the bag using two or more grasped steering sleeve elements. Thus, the catheter may be held in a restricted shape with only one hand, allowing the other hand to hold the bag open to receive the catheter.

According to a fourth aspect of the present invention there is provided a method of using a catheter, wherein the catheter comprises at least one steering sleeve configured to provide at least two steering sleeve elements, the method comprising: introducing a catheter into the body; removing the catheter from the body using at least one steering sleeve of the catheter; and disposing the catheter in the pouch using at least two steering sleeve elements.

The method may include providing a packaged catheter assembly including a catheter held within a pouch. The method may include opening the bag and removing the catheter from the bag.

In the case where the catheter is a male urinary catheter, the method can further include introducing the catheter into the urethra through the proximal end of the catheter. The method may include releasing urine through a funnel at the distal end of the catheter. The method may further comprise removing the catheter.

In the method of using a catheter, the packaged catheter assembly may be a packaged catheter assembly as generally defined, or may optionally include any of the optional features described above in accordance with the second aspect described above. Indeed, it may comprise any optional feature, not necessarily all features set out in the second aspect above.

The method of using a catheter may optionally further comprise any of the features described in the method of packaging a catheter according to the third aspect above. It may comprise any optional feature, not necessarily all features set out in the third aspect above.

Detailed Description

Drawings

For a clearer understanding of the invention, one or more embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

FIG. 1 is an exploded view of a first embodiment of a packaged catheter assembly;

FIG. 2 is a front view of the seal assembly of FIG. 1;

FIG. 3 is a front view of the packaged catheter assembly of FIGS. 1 and 2, wherein fluid has been released into the pouch;

fig. 4 is a front view of the catheter assembly of the package of fig. 1-3, wherein the package has been opened;

FIG. 5 is a front view of the packaged catheter assembly of FIGS. 1-4, with the catheter having been partially removed from the bag;

FIG. 6 is a front view of the packaged catheter assembly of FIGS. 1-5, with the catheter having been almost completely removed from the bag;

FIG. 7 is a steering sleeve configured to be separable into two steering sleeve elements;

FIG. 8 is the steering sleeve of FIG. 7 separated into two steering sleeve elements;

FIG. 9 is a catheter of the packaged catheter assembly of FIGS. 1-6, wherein the steering sleeve has been separated into two steering sleeve elements;

FIG. 10 is the catheter of FIG. 9 wrapped with two steering sleeve elements prior to repacking;

FIG. 11 is a front view of the used and repackaged catheter assembly of FIGS. 1-6;

FIG. 12 is a front view of a second embodiment of a packaged catheter assembly; and

fig. 13 is an enlarged schematic view of a portion of the inner surface of the steering sleeve of fig. 7.

In the figure, conventionally, the broken line shows the occluded feature.

Detailed Description

The present invention relates to a catheter, in particular a steering sleeve for a catheter. It is described in the context of a packaged catheter assembly. The packaged catheter assembly includes a pouch and a catheter. The catheter is disposed within the bag. The catheter includes at least one steering sleeve configured to provide at least two steering sleeve elements after removal of the catheter from the pouch. Thus, the two steering sleeve elements may be used separately to better steer the catheter without touching its surface. In the described embodiment, the two actuating sleeve elements are initially provided as two halves of a single actuating sleeve, which is frangible in order to be separable into the two actuating sleeve elements. Of course, it will be immediately understood that in another embodiment, the catheter is initially provided with two separate steering sleeves, each providing a separate steering sleeve element.

Referring to fig. 1-11, a first embodiment of a packaged catheter assembly 100 is shown.

The assembly 100 includes a fluid reservoir 10, a male intermittent disposable urinary catheter 20, and a pouch 30. Catheter 20 includes a proximal end 21 for insertion into the body, a distal end 22, and a flexible tube 23 connecting ends 21, 22. The distal end 22 includes a funnel 24 to direct urine from the bladder out of the tube 23 in use. A steering sleeve 25 is also provided around the tube body 23 and is disposed near the distal end 22. The handling sleeve 25 comprises a weakened portion, which in this embodiment is a row of perforations 26 extending around the circumference of the handling sleeve 25. The perforations 26 are rupturable so that the steering sleeve 25 can be separated into two steering sleeve elements, a proximal element 25a and a distal element 25b, as described below.

In this embodiment, the catheter tube 23 is a hydrophilic thermoplastic elastomer (TPE), and the steering sleeve 25 and steering sleeve elements 25a, 25b are formed from a Low Density Polyethylene (LDPE) film. The funnel 24 is made of polyvinyl chloride (PVC).

In this embodiment, the pouch 30 includes an opaque front wall 31a, an opaque rear wall 31b, and peripheral seals connecting the peripheries of the walls 31a, 31b together to form the pouch. The peripheral seal includes a base 32, a right side edge 33, a left side edge 34, and an upper edge 35. When viewing the bag 30 with the rear wall 31b behind the front wall 31a, the base 32 at the bottom of the bag 30, and the upper edge 35 at the top of the bag 30, the left side edge 34 and the right side edge 33 are defined as the left side and right side of the bag. Thus, the peripheral seal defines a pocket 30, the pocket 30 being generally rectangular and suitably having a width between the side edges of 60-110mm, such as about 100mm, such as 95mm, and a height from the base 32 to the upper edge 35 of 100-250mm, such as about 200mm, such as 197mm. The base 32 defines the bottom of the bag in use and the upper edge 35 defines the top. However, in other embodiments, alternative shapes and sizes are contemplated, such as oval or circular bags.

The bag further comprises a junction 36 between the two walls 31a, 31 b. The joint 36 is an annular weld that is provided at an equidistant point between the side edges 33, 34 of the peripheral seal and extends a distance of 45mm to 55mm above the base 32. The radius of the junction 36 may be between 1% and 10% of the height of the bag, for example 5%. In other embodiments, the joint may be provided in different shapes and sizes at different locations, or may even be integrated with the peripheral seal as a continuous seal.

The bag further comprises a window 37 in one of the walls, which allows the user to see the interior of the bag. In this particular embodiment, window 37 is transparent and elongated and is generally rectangular with a length between 20% and 50% of the height of bag 30, such as 33% of the height of bag 30, and a width between 5-25% of the width of bag 30, such as 12.5% of the width of bag 30. In this example, the windows 37 have semi-circular ends, but in other embodiments they may be any suitable shape, such as flat ends or irregularly shaped ends. The window 37 is arranged parallel to the right side edge 33 and a gap is provided between the edge of the window 37 and the right side edge 33, which gap is equal to 5-20%, for example 10%, of the width of the bag. The bottom of the window 37 is spaced from the base of the peripheral seal 32 a distance equal to 5-20%, for example 10%, of the height of the bag. In other embodiments, a translucent window may be used, and additional alternative shapes, sizes, and positions or angles of the window (e.g., angles up to 20 degrees with respect to the edge) are contemplated.

In this particular embodiment, each wall 31a, 31b comprises a plurality of foil layers; in one specific embodiment, is a 97 micron double layer foil comprised of 12 micron PET and 60 micron LLDPE. In other embodiments, the walls 31a, 31b may comprise only a single layer, and different plastic materials may be used interchangeably.

As mentioned above, the walls 31a, 31b are opaque. This may be achieved by forming each wall 31a, 31b from one or more layers of opaque material or printing an opaque pattern onto one of the layers. The window 37 in the front wall 31a may be formed by laminating a layer of opaque material to the transparent wall, wherein the opaque layer has apertures corresponding to the window 37. Alternatively, a transparent wall may be printed to block light from passing through the wall, making it opaque everywhere except at the location of window 37. Further alternatives are also conceivable and implemented, for example, providing a hole in the opaque wall corresponding to the window 37 and incorporating a transparent layer so as to cover the hole and realize a continuous front wall 31a with the window 37, or starting from a multilayer foil with an opaque layer and a transparent layer and removing a portion of the opaque foil layer to form a transparent window.

In this particular embodiment, the pouch further comprises an interaction region. The interaction region forms the top portion of the pouch 30 and spans between the right side edge 33 and the left side edge 34. The interaction zone is used to provide access to the bag through/near the upper edge 35. In this embodiment, the interaction region comprises a tapered tear region 38 and a sealing means 39. Tear region 38 includes a tear initiation 40 located on the left side edge about 2cm below the intersection of upper edge 35 and left side edge 34, and a tear stop 41 located about 1cm below the intersection of upper edge 35 and right side edge 33 in pouch 30. The distance between the tear stop 41 and the right edge 33 is between 1% and 10% of the width of the bag, for example 5%. The tear initiation 40 includes a notch for providing a region of weakness in the walls 31a, 31b, allowing the tear region 38 to be separated from the pouch 30 by tearing the wall from the tear initiation 40 to the tear stop 41. Thus, the tear is located below the position of the upper edge 35, and thus the pouch 30 is opened to provide access to its contents. Tear stop 41 includes small holes in walls 31a, 31b to prevent further tearing of bag 30 and separation of tear region 38 from bag 30. To provide the tapered shape, tear region 38 extends approximately 50% more on the left side than on the right side. The left side of the tear area 38 includes a circular aperture 42 sized to allow a finger to pass through and grasp the tear area 38. To ensure that the bag is fully sealed, the front wall 31a and the rear wall 31b are sealed to each other around the tear stop 41 and the perimeter of the circular aperture 42. In other embodiments, other seals, such as a zipper lock device, may be used to provide access to the bag, although the above sizes and shapes are exemplary.

In this embodiment, the sealing means 39 extends between the left side edge 34 and the right side edge 33 of the peripheral seal just below the tear area 38. The sealing means 39 comprises a first and a second sealing member (not shown) arranged on the inner surface of the walls 31a, 31b of the bag 30. In this embodiment, the sealing members include respective sealing grooves and ridges to allow the sealing members to be press-fit together to form a watertight/watertight seal and pulled apart again if required. In other embodiments, a single adhesive sealing member may be used, or a sealing member may be provided on the outside of the bag to allow the bag to be folded or rolled up and sealed accordingly, although alternative sealing mechanisms, such as a hook-and-loop sealing mechanism or a hook-and-hook sealing mechanism or a zipper lock, may be used.

In this embodiment, the fluid reservoir 10 is an elongate rectangular burstable water bladder, but in other embodiments any suitable reservoir may be used. The height of the fluid reservoir 10 is equal to 60-90%, e.g. 80%, of the height of the bag 30 and the width is 5-25%, e.g. 15%, of the width of the bag 30. In this embodiment, the fluid contained within the reservoir 10 is water. In other embodiments, many other types of reservoirs will be suitable, including reservoirs of different shapes and sizes, or non-burstable reservoirs and other external fluid sources. In addition, other fluids may be used, such as lubricants, gels, oils, and the like.

In this embodiment, the catheter 20 has a length of 30-50cm, such as 40cm, and the steering sleeve 25 is 10-30%, such as 20-25%, such as 11cm, of the length of the catheter 20. In this embodiment, the perforation 26 is located at a midpoint along the length of the steering sleeve 25. Thus, the distal element 25b constitutes the half/half of the steering sleeve 25 closest to the distal end 22 of the catheter 20, and the proximal element 25a constitutes the half/half of the steering sleeve 25 closest to the proximal end 21 of the catheter 20.

Referring to fig. 7, in this embodiment, the steering sleeve 25 is formed from two strips of elongate material (e.g., a first strip 51 and a second strip (not shown)) joined along their respective left and right elongate edges, such as by welding, to form left and right edges 52 and 54 of the steering sleeve 25. The steering sleeve 25 is frustoconical with a width of 17mm at the open proximal end 53 corresponding to the proximal element 25a and 23mm at the opposite open distal end 55 corresponding to the distal element 25 b. Advantageously, this allows the wider distal end 55 of the steering sleeve 25 to cover the funnel 24 when needed, while the thinner proximal end 53 of the steering sleeve 25 prevents the steering sleeve from being removed from the catheter 20. The width of the actuating sleeve 25 varies linearly along its length, and is therefore 20mm in width at the perforation 26. Each of the elongate strips forming the handling sleeve 25 has a length of 110mm and is therefore an isosceles trapezoid with a base of 23mm, a top of 17mm and a height of 110 mm. Thus, the strips are joined along their oblique edges to form the steering sleeve 25.

In this embodiment, prior to engagement of the elongate edges 52, 54, the steering sleeve 25 is perforated across its width along half of its length to form perforations 26, thereby providing the two separable steering sleeve elements 25a, 25b. In this embodiment, the perforations 26 comprise a row of elongate holes extending around the circumference of the steering sleeve 25. The width and length of these holes are perpendicular to the width and length of the handling sleeve 25, respectively. In this embodiment, the holes are slits, so they are one-dimensional and have an aspect ratio (length: width) much greater than 2:1 and effectively 1:0.

In this embodiment, the holes are spaced apart by a distance no greater than the length of each hole, and in this example, the holes are spaced apart by 1mm. In this embodiment, the length of each hole is 2mm. Thus, the perforations 26 provide a weak spot in the handling sleeve 25 sufficient to allow easy separation of the handling sleeve 25 into the two handling sleeve elements 25a, 25b. Furthermore, because they are slits, they reduce the likelihood of accidental contact of the catheter 20 through the hole when the catheter 20 is maneuvered. This helps to ensure that the catheter 20 remains clean and sterile prior to use.

In this embodiment, the catheter 20 is provided with a hydrophilic coating that is activated when it contacts the fluid contained in the reservoir 10. In other embodiments, any suitable catheter length or type may be used. Referring to fig. 13, in this embodiment, the inner surface 56 of the handling sleeve 25 is hydrophobic and comprises an embossing pattern 57. This reduces friction between the catheter 20 and the steering sleeve 25, allowing for easier placement of the sleeve along the catheter 20 during use. In this example, the embossed pattern 57 is a linen pattern.

The catheter 20 is disposed within the pouch 30 in a curved and coiled configuration with the distal end 22 located near the inner left edge 33 adjacent the upper edge 35 of the pouch 30, i.e., just below the sealing device 39. The conduit 20 extends downwardly along the interior of the bag 30 into a generally oval-shaped counterclockwise coil (viewed from the left side edge 34 to the left and the upper edge 35 to the top). The coil has a single turn around the inner circumference of the left side edge 34, base 32, and right side edge 33 of the pouch, with the proximal end 21 of the catheter 20 resting inside the catheter coil adjacent the left side edge 34 and base 32 of the pouch. Note that most of the handling sleeve 25 is arranged above the joint 36, and thus the perforation 26 is arranged above the joint 36. When the catheter 20 is bent and extends from left to right, the catheter tube 23 extends below the junction, in a channel defined by the junction and the inner base of the peripheral seal, then extends up to the side of the junction, then returns over the top of the junction, and finally extends downward such that the proximal end 21 is below the junction 36 and to the left of the junction 36. Briefly, catheter 20 is coiled (or curled) around junction 36 (although not tightly coiled). In other embodiments, the position of the catheter 20 may be different, in particular, the catheter 20 may not be coiled or curled, but may simply be bent within the pouch 30. In another aspect, embodiments of the present invention may have a catheter 20 with multiple turns of coils.

Referring to fig. 2, the pouch 30 is formed by: first two walls 31a, 31b are provided defining the bag 30 itself, wherein the front wall 31a comprises a transparent window 37 as described above and is produced by one of the techniques described above. In this embodiment, the walls 31a, 31b are sized to correspond to the final shape of the bag 30, however in other embodiments the walls may extend to the exterior of the bag 30 as desired.

In this embodiment, the base 32, right side edge 33 and left side edge 34 are formed by first welding the two walls 31a, 31b together and leaving the upper edge 35 of the pouch 30 open. The catheter 20 is then disposed within the pouch 30 in a curved and coiled configuration, as described above.

In this embodiment, the fluid reservoir 10 is also placed within the bag 30 at a location corresponding to the window 37. The reservoir 10 is placed over the catheter 20 such that the reservoir 10 is visible through the window 37 and the reservoir 10 blocks any view of the catheter 20 through the window 37. In other embodiments, reservoir 10 may not need to be placed over catheter 20, as the position of catheter 20 in pouch 30 may not correspond to window 37.

In this embodiment, first and second sealing elements (not shown) are then attached to the inside of the walls 31a, 31b directly above the coiled conduit 20, and the peripheral seal is accomplished by welding the walls 31a, 31b together along the upper edge 35 to form the upper edge 35 thereof. This seals the catheter 20 and reservoir 10 within the pouch 30. In other embodiments, the sealing element may be provided to the wall prior to any other assembly of the bag 30 or sealing of the peripheral seal.

In this embodiment, the joint 36 is then formed by welding the walls 31a, 31b together. Because the catheter 20 surrounds the interior Zhou Panrao of the pouch 30, the junction 36 is located within the coil of the catheter 20. Thus, a portion of the catheter tube 23 passes between the junction 36 and the base 32 of the pouch. In other embodiments, the interface 36 may be provided prior to the perimeter seal, or at any point during the assembly process.

Finally, in this embodiment, tear initiation 40, tear stop 41, and aperture 42 may be formed by cutting away the appropriate portions of bag 30. The walls 31a, 31b may be bonded simultaneously around the perimeter of the cut-out region using a thermal punch to ensure that the pouch 30 remains completely sealed.

It will be appreciated that the above is an example, and that in other embodiments, the pouch 30 may be formed differently, with the steps performed in a different order. For example, the bottom may be open and the conduit 20 and the reservoir 10 of water introduced from the bottom before the base seal 32 is provided. Alternatively, for example, in the course of industrial applications, the two webs of wall material may have half of the sealing means applied to (the inner surface of) each of them, the conduit 20 and the reservoir 10 may be arranged between the opposite inner surfaces of the webs of wall material, and then potentially in a single action the hot dies may engage and form the walls 31a, 31b by: by forming the peripheral seal portions 32, 33, 34, 35, the tear initiation 40, the joint 36, and the hole 42 and the tear stop 41 are simultaneously formed and punched and sealed in the interaction region 38. Further, while the peripheral seal and the junction 36 have been described as being formed by welding, any suitable means for joining the walls may be used, for example, an adhesive may be used.

2-9, a first embodiment of the packaged catheter assembly 100 may be unpackaged as described below.

First, the fluid reservoir 10 is positioned into the bag 30 with the aid of the window 37, the reservoir 10 being visible through the window 37. The fluid is then released from the reservoir 10 into the bag 30. In this embodiment, the reservoir 10 is a rupturable pouch and fluid may be released therefrom by applying manual pressure to the reservoir 10. Window 37 provides a visual reference to indicate when the reservoir has been successfully ruptured and the fluid is released into bag 30. In particular, it can be seen that sufficient fluid has been released to fill the channel defined by the weld 36 and the inner base 32 of the peripheral seal. In other embodiments, the fluid may be released from other devices.

Referring to fig. 3-6, the fluid released from reservoir 10 is collected in a pool at the bottom of bag 30, as indicated by the dashed line. In this embodiment, the fluid fills the bag 30 up to a fill level corresponding to the junction 36. Thus, in this embodiment, the engagement portion 36 and the base portion 32 define a channel that is completely filled with fluid. However, in other embodiments, the fluid may only partially fill the channels, such as 60-95% of the fill channels, or the bag may be filled to a height above the junction 36.

The released fluid can also be seen through the window 37, as the base of the window 37 corresponds to a position on the bag 30 slightly below the junction 36. In other embodiments, the window may include an indicator region that displays the presence of fluid in the bag. Such as color-changing strips that are sensitive to the fluid, so that direct viewing of the fluid is not required. A fill level indicator may also be provided to indicate that sufficient fluid has been released.

In this embodiment, the contents of the bag 30 are then accessed by tearing the top of the bag 30 using the tear area 38. The perforations 42 are grasped with one hand and the remainder of the bag 30 is grasped with the other hand, tearing the tear region 38 from the tear initiation 40 to the tear stop 41. Thus, the bag is torn between the left and right edges 34, 33 at a position below the upper edge 35, such that an opening is formed in the bag 30, which opening can be used for access to its contents. Advantageously, tear region 38 does not completely separate from pouch 30, which reduces the number of separate portions and makes pouch 30 easier to handle. Other embodiments may feature other ways of accessing the bag, such as a zipper lock seal.

Referring to fig. 4-6, catheter 20 may then be removed from pouch 30. As described above, in this embodiment, the catheter 20 is coiled within the pouch 30 and the distal end 22 is disposed adjacent the upper edge 35 of the pouch 30. In this way, the distal end 22 is positioned above the fill line of fluid released into the pouch 30 and is not wetted by the fluid. Thus, the distal end 22 provides a dry and easily accessible point that can be used to remove the catheter 20 from the pouch 30. In this embodiment, the majority of the handling sleeve 25, i.e. 60-100%, for example 70% of the sleeve 25, is also above the filling line and is not wetted. Thus, sleeve 25 also provides a convenient dry surface for maneuvering catheter 20. In particular, the distal steering sleeve member 25b is entirely/entirely located above the filling line and is therefore dry.

In this embodiment, distal end 22 is pulled upwardly through an opening in upper edge 35 of bag 30. As distal end 22 is pulled out of pouch 30, catheter tube 23 is deployed and also pulled upward toward upper edge 35 of pouch 30. However, since the engagement portion 36 is disposed within the coil of the catheter 20, the engagement portion 36 prevents the tube body 23 from moving directly upward. Thus, the engagement portion 36 allows the tube 23 to be removed from the bag 30 along a path that includes a passage through the channel defined by the engagement portion 36 and the base 32. In this way, the entire remainder of the tube body 23 to the proximal end 21 passes through the fluid pool in the channel and the hydrophilic coating of the catheter 20 is activated by the fluid. In addition, the proximal end 21 of the catheter 20 is the last portion of the catheter 20 to pass through the passageway and be withdrawn from the pouch 30. Thus, when the catheter 20 is withdrawn, the catheter 20 is activated by the fluid and the withdrawal is convenient and easy since only the dry portion of the catheter 20 needs to be contacted during withdrawal. As the conduit 20 passes through the fluid cell, it is more completely wetted with fluid contained in another medium, such as foam. In other embodiments, the conduit 20 need not be directly withdrawn upwardly, but rather may be pulled laterally from the bag, for example from an opening provided in the side of the bag, but of course above the weld, in order to reduce the likelihood of spillage. Further, the conduit 20 may not directly contact the junction 36, but rather the conduit 20 may be prevented from moving upward by the convergence of the walls 31a, 31b as they approach the junction 36.

Once the catheter is completely removed, the catheter can be used by inserting the proximal end 21 into the urethra until urine begins to flow through the catheter 20. The (very dry) handling sleeve 25 facilitates the insertion. Urine may then be directed out of catheter 20 through funnel 24.

Referring to fig. 7-11, catheter 20 may be placed back into pouch 30 in a coiled configuration after use. The steering sleeve 25, including the proximal and distal elements 25a, 25b, and the funnel 24 provide a dry surface that can be used to rewind the catheter 20 and place it in the pouch 30. The catheter 20 may be repackaged back into the pouch 30 as described below.

Referring to fig. 7-9, the steering sleeve 25 can be separated into a proximal element 25a and a distal element 25b. This may be done either before or after use of the catheter 20, depending on the requirements of the user. In this embodiment, the perforations 26 may be broken around the circumference of the steering sleeve 25 in order to separate the steering sleeve 25. The proximal element 25a and the distal element 25b are thereby provided on the catheter 20. In this embodiment, each of the steering sleeve elements, proximal element 25a and distal element 25b, are independently movable along the length of catheter 20 to facilitate ease of use.

In this embodiment, the catheter 20 is then looped and knotted to limit its size/shape and allow for easy repackaging. First, the proximal element 25a is disposed at a first section of the catheter near or at the proximal end of the catheter 20, and the distal element 25b is disposed at a second section of the catheter 20 between the midpoint and the distal end of the catheter 20. Second, the proximal element 25a may be used to form a loop in the catheter 20 between the first and second sections.

The proximal element 25a may then be used to insert the proximal end of the catheter 20 into the distal element 25 b. Thus, the proximal end of the catheter 20 may be received by and retained within the distal element 25b by the distal element 25b proximate the second section of the catheter 20. Thus, the sleeve elements 25a, 25b are manipulated to tightly encircle the catheter 20. In other embodiments, multiple rings may be implemented to further limit the size/shape of catheter 20 as desired.

To further limit the size/shape of the catheter 20, in this embodiment, the catheter 20 is then knotted. By passing the distal end of the catheter 20 through the loop, a knot is formed in the catheter 20. In this embodiment, this is accomplished by holding distal element 25b to maintain the annular shape of catheter 20, and then passing funnel 24 through the loop using funnel 24 itself (of course, funnel 24 is not inserted into the urethra in use, is therefore clean, and does not have a hydrophilic surface, and therefore does not slip, and is also easy to grasp). Thus, the size/shape of the catheter may be further limited by looping the catheter.

After looping and knotting, catheter 20 may be held in this form using a single hand that grasps distal element 25 b. The bag 30 may then be held in the other hand of the user and the catheter 20 placed within the bag 30. Advantageously, the loop and knot prevent the end of the conduit 20 from being caught by the sides of the bag 30 and allow the conduit to easily pass through the opening in the upper edge 35 of the bag 30.

The sealing device 39 can then be used to reseal the bag 30 between the left side edge 34 and the right side edge 33 by pressing two corresponding sealing elements (not shown) together. This allows for easier disposal/disposal of the catheter 20 after use and ensures that fluid released into the bag 30 does not subsequently leak out of the bag 30. In other embodiments, alternative sealing means may be used, such as an external flap with adhesive, which allows the top of the pouch 30 to be rolled or folded and sealed. Alternatively, the sealing means may not be used in case the bag 30 is intended to be discarded immediately after use.

Referring to fig. 8, a second embodiment of a packaged catheter assembly 200 is shown. The second embodiment shares many of the features of the first embodiment described above, so only differences in features will be described below, and like reference numerals are used to designate like features.

In this embodiment, the joint 236 is disposed at a position offset from the midpoint between the right side edge 233 and the left side edge 234. In particular, the engagement portion is disposed at a distance from the right edge 234 that is 20-45%, such as 35%, of the width of the pocket 230. The joint 236 provides a second function as a retention seal for restricting movement of the reservoir 210 in the bag 230, sandwiching the reservoir 210 between the joint 236 and the right side edge 234. Thus, the engagement 236 ensures that the window 237 corresponds to the position of the reservoir 210 regardless of the movement of the pouch 30 that occurs when it is carried around by a user, thereby ensuring that the catheter 223 remains hidden and that the reservoir 210 can be easily identified to release its fluid. In other embodiments, the function of the retention seal may be provided by a separate seal between the walls 231a, 231 b. Such as a separate seal extending downwardly from the seal 239 or upwardly from the base 232.

In this embodiment, the front wall 231a also includes a pattern 243 corresponding to the edge of the window 237. The pattern 243 is shown only on a portion of the window, but of course may extend over the entire window and include a gradual appearance that softens the boundary between the transparent window 237 and the rest of the opaque front wall 231 a. In this embodiment, the pattern is a series of uniformly spaced opaque lines having a gradual thickness so as to thin as they approach the center of the window 237. In this way, the pattern 243 makes the window 237 less visually apparent, thus making the bag 230 less noticeable. In other embodiments, the pattern 243 may be any suitable pattern, such as opaque circles having graded/graded dimensions, and may be supplemented by or integrated with the surface pattern or color applied to the reservoir 210.

Conditional language such as "capable," "may," or "may" is generally intended to convey that certain embodiments include certain features, elements, and/or steps, while other embodiments do not, unless specifically stated otherwise or otherwise understood in the context of the use. Thus, such conditional language is not generally intended to imply that one or more embodiments require features, elements and/or steps in any way or that one or more embodiments must include logic for deciding, with or without user input or prompting, whether these features, elements and/or steps are included in any particular embodiment or are to be performed.

The one or more embodiments are described by way of example only. Many variations are possible without departing from the scope of protection provided by the appended claims.

Claims

1. A packaged catheter assembly comprising a pouch and a catheter, wherein: the catheter is disposed in the bag; the catheter includes at least one steering sleeve formed of a film material configured to provide at least two steering sleeve elements after removal of the catheter from the pouch.

2. The catheter assembly of claim 1, wherein the catheter comprises one steering sleeve configured to provide at least two steering sleeve elements.

3. The catheter assembly of claim 2, wherein each steering sleeve element corresponds to 30% -70% of the length of the steering sleeve.

4. The catheter assembly of any of the preceding claims, wherein at least one of the at least two steering sleeve elements is configured to simultaneously receive two or more sections of the catheter.

5. The catheter assembly of any one of the preceding claims, at least one of the at least two steering sleeve elements being arrangeable to retain the catheter in an annular or coiled configuration.

6. The catheter assembly of any of the preceding claims, wherein at least one steering sleeve comprises a weakened portion comprising one or more perforations disposed about a circumference of the respective steering sleeve.

7. The catheter assembly of claim 6, wherein the perforations comprise a row of holes, wherein the holes are spaced apart by a distance that is no greater than a length of each hole in a direction parallel to a circumference of the respective steering sleeve.

8. The catheter assembly of claim 6 or 7, wherein the catheter comprises one steering sleeve that can be separated at the puncture to provide two steering sleeve elements.

9. The catheter assembly of any one of claims 6 to 8, wherein each aperture is a slit.

10. A catheter assembly according to any preceding claim, wherein the inner surface of the or each steering sleeve comprises an embossed pattern.

11. The catheter assembly of any of the preceding claims, wherein at least one steering sleeve forms a sheath around at least a portion of the catheter, at least one steering sleeve element of the at least two steering sleeve elements forming a sheath around only a portion of the catheter.

12. The catheter assembly of any of the preceding claims, wherein at least one of the at least two steering sleeve elements is independently movable along the length of the catheter.

13. The catheter assembly of any one of the preceding claims, wherein the catheter comprises a distal end and a proximal end for insertion into the body, a funnel at the distal end of the catheter, and at least one steering sleeve arranged adjacent to the funnel prior to use.

14. The catheter assembly according to any of the preceding claims, wherein the catheter comprises a distal end and a proximal end for insertion into the body, the at least two steering sleeve elements comprising a proximal element disposable at or near the proximal end and a distal element disposable at or near the distal end.

15. The catheter assembly of claim 14, wherein the distal element is further disposable between a midpoint and a distal end of the catheter.

16. The catheter assembly of claim 14 or 15, wherein the distal element is configured to receive a proximal end of the catheter.

17. The catheter assembly of any of the preceding claims, wherein at least one steering sleeve has a constant width measured perpendicular to an axis of the catheter.

18. The catheter assembly of any one of claims 1-16, wherein the at least one steering sleeve is tapered.

19. The catheter assembly of any one of the preceding claims, wherein the at least one steering sleeve is formed from one or more strips of material joined together along an edge thereof.

20. The catheter assembly according to any of the preceding claims, wherein the catheter is a male urinary catheter.

21. A method of packaging a catheter, the catheter comprising at least one steering sleeve, the method comprising: providing at least two steering sleeve elements; and disposing the catheter in a pouch using the steering sleeve member.

22. The method of claim 21, comprising the step of providing the packaged catheter assembly of any one of claims 1 to 20 in an unpackaged state.

23. A method according to claim 21 or 22, comprising the step of separating at least one steering sleeve into at least two steering sleeve elements.

24. The method of any one of claims 21 to 23, comprising the step of moving one or more of the at least two steering sleeve elements along at least a portion of the length of the catheter.

25. The method of any one of claims 21 to 24, comprising the step of coiling or looping the catheter.

26. The method of any one of claims 21 to 25, comprising forming a knot in the catheter.

27. The method of any one of claims 21 to 26, comprising forming a loop in the catheter and thereafter forming a knot in the catheter.